Essure is a permanent birth control product that received Food and Drug Administration (FDA) approval in 2002 for use as a contraceptive. Bayer has carried out aggressive marketing campaigns for Essure that have been called into question by both consumers and attorneys for deceptive advertising.
These marketing campaigns promise women Essure is a permanent solution for birth control that does not require surgery. Advertisements have also claimed Essure is safer and more effective than other means of permanent birth control. Let’s see what the facts say about these claims.
Is Essure the Safest Permanent Birth Control Option?
To prevent pregnancy, Essure uses small metal coils that are inserted into the fallopian tubes. These coils create tissue growth within the fallopian tubes that block sperm from reaching the eggs. However, the coils can cause serious health problems for women.
The FDA has received thousands of complaints from women who suffered injuries caused by Essure. Injuries mentioned in the complaints include perforation of the uterus or fallopian tubes, device migration, punctured organs, allergic reactions and chronic pain. Additional complaints suggest Essure failed to prevent birth and has caused fatal health complications for babies and mothers.
The FDA has received so many complaints that it required Essure to be sold with a black box warning earlier this year. In addition, the FDA required Bayer to use a patient decision checklist, a five-page document that patients go over with their physicians to understand possible risks.
Research published by the British Medical Journal discovered Essure carries a risk of chronic pain and injury that may require surgical procedures to remove the device. British Medical Journal claims the risk of reoperation is tenfold higher when compared to patients who underwent laparoscopic sterilization, a procedure where the fallopian tubes are clamped.
An FDA investigation into Essure discovered that from 2008 to 2010, more than 16,000 adverse event reports were sent to Bayer. Bayer reported just 183 of these events to the FDA.
Do Women Injured by Essure Have Legal Options?
Bayer has a duty to warn the public of possible injuries associated with using Essure. Women who have been harmed by Essure may have legal options to hold Bayer accountable.
The New Jersey personal injury attorneys at Keefe Law Firm have a proven record of helping people who have been injured by dangerous consumer products.